Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation
Authors: Mohit K. Turagam, Petr Neuzil, Boris Schmidt, Tobias Reichlin, Kars Neven, Andreas Metzner, Jim Hansen, Yuri Blaauw, Philippe Maury, Thomas Arentz, Philipp Sommer, Ante Anic, Frederic Anselme, Serge Boveda, Tom Deneke, Stephan Willems, Pepijn van der Voort, Roland Tilz, Moritoshi Funasako, Daniel Scherr, Reza Wakili, Daniel Steven, Josef Kautzner, Johan Vijgen, Pierre Jais, Jan Petru, Julian Chun, Laurent Roten, Anna Füting, Marc D. Lemoine, Martin Ruwald, Bart A. Mulder, Anne Rollin, Heiko Lehrmann, Thomas Fink, Zrinka Jurisic, Corentin Chaumont, Raquel Adelino, Karin Nentwich, Melanie Gunawardene, Alexandre Ouss, Christian-Hendrik Heeger, Martin Manninger, Jan-Eric Bohnen, Arian Sultan, Petr Peichl, Pieter Koopman, Nicolas Derval, Thomas Kueffer, Vivek Y. Reddy
Journal: JAMA Cardiology (2023)

Importance Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile. Objective To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry. Design, Setting, and Participants This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF. Exposure PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator. Main Outcomes and Measures The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (&amp;amp;lt;7 days postprocedure) and chronic (&amp;amp;gt;7 days) major adverse events (MAEs). Results Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P &amp;amp;lt; .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P &amp;amp;lt; .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P &amp;amp;lt; .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19). Conclusion and Relevance Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.